FDA就低成本生物仿制药再发声明：化学合成多肽被排外！

今日，FDA就低成本生物仿制药和可互换蛋白质产品（包括目前市场上的每一种胰岛素）再发声明。

胰岛素是许多美国人用来治疗糖尿病的一种救命药。然而，近年来，胰岛素产品价格的上涨引起了许多患者对获得生存所需胰岛素能力的严重担忧。据了解FDA举行了公开听证会，听取利益相关者的意见，FDA还准备提交和审查生物仿制药和可互换胰岛素产品的申请。据FDA预计，这些产品一旦获得批准，将给胰岛素市场带来新的竞争，并有助于为糖尿病患者提供负担得起的治疗选择。

上个月FDA发布了《提高生物仿制药和可互换胰岛素产品开发效率的声明》（请参考：https://mp.weixin.qq.com/s/bC18APsqlZju5uolU5RN1Q），该声明是为了帮助更多的糖尿病患者获得更好的治疗方法，其中还解释了《生物相似或可互换胰岛素产品的临床免疫原性注意事项》指导草案。

在今天的声明中，FDA提到从2020年3月开始，大多数被批准为药物产品的蛋白质产品将面临生物仿制药和可互换产品的竞争。然而，“化学合成多肽”被排除在这一转变之外，这意味着属于“化学合成多肽”类别的产品将无法作为生物仿制品或可互换产品进入市场，必须以不同与前两者的途径进入市场。这类产品也无法通过仿制药途径进入市场，因为原始产品将被归类为生物制剂。这种排除可能会损害这类产品竞争力，因为这意味着，如果开发人员用化学方法合成一种蛋白质产品的仿制药（如胰岛素仿制药），该产品将无法通过生物仿制药或可互换的途径进入市场，而是必须提交一份新的药物申请，这可能需要更多的资源。

FDA表示“化学合成多肽”类仿制产品将有助于患者，因为它为化学合成的后续胰岛素和其他蛋白质产品提供了通过更有效的简化途径，提升了进入市场的潜力。除了扩大获得低成本生物仿制药和可互换蛋白质产品的机会外，“化学合成多肽”类仿制产品将有助于促进制造方法的潜在创新，这可能提升未来制造过程的效率。

这些措施都是FDA为了确保一条有效的途径将潜在的低成本生物仿制药和可互换蛋白质产品推向市场，扩大这些产品的准入和增加竞争，最终帮助美国患者。

声明原文：

Statement on low-cost biosimilar and interchangeable protein products

Statement From:Deputy Commissioner for Policy, Legislation, and International Affairs - Food and

Drug Administration

Anna Abram

Director - Center for Drug Evaluation and Research

Janet Woodcock M.D.

Ensuring an efficient pathway to bring potentially lower-cost biosimilar and interchangeable protein products to market is key for expanding access to these products and increasing competition, ultimately helping American patients.

In March 2020 most protein products that were approved as drug products (including every insulin currently on the market) will open up to biosimilar and interchangeable competition. However, “chemically synthesized polypeptides” are excluded from this transition, which means that a product that falls within this category won’t be able to come to market as a biosimilar or interchangeable product, but will have to come to the market under a different pathway. Such a product would also not be able to come to market through the generic drug pathway because the originator product will have been classified as a biologic, and will not be available for copying. This exclusion could hurt potential competition because it means that if a developer were to chemically synthesize a copy of a protein product (e.g., an insulin copy), the product would not be able to come to market through the abbreviated biosimilar or interchangeable pathway, but instead would have to submit a new drug application, which could be much more resource-intensive.

Removing this exclusion will help patients because it provides the potential for chemically synthesized follow-on insulins and other protein products to come to market through more efficient abbreviated pathways, regardless of how they are manufactured. In addition to expanding access to lower-cost biosimilar and interchangeable protein products, removing this exclusion will help to promote potential innovation in manufacturing methods, which could lead to future efficiencies in manufacturing processes.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

原文：http://suo.im/6xdcHu